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To Research The Preparation Process And Quality Standards Of Gastrodia Elata

Posted on:2015-04-21Degree:MasterType:Thesis
Country:ChinaCandidate:P YuFull Text:PDF
GTID:2284330431980319Subject:Chinese materia medica
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Gastrodiae rhizoma is dry tubers of Gastrodia elata Bl.which one of the raretraditional Chinese medicinal materials in common use,for calming liver wind andactivating meridians stop pain.it’s mainly used for treating dizziness, limb numbness,ear source sex, epilepsy, high blood pressure, vertigo, etc.This topic is about "Chinesepharmacopoeia"2015edition of scientific research tasks "Tianma quality standardresearch" and "TLC identification with contrast extract".It’s mainly around the TLCidentification, extract,determination of content, to conduct research and methodologyvalidation revised Tianma quality standards; Drafted the Tianma powder qualitystandards and use the reference extracts as control materials for TLC at the first time.1. To revise Tianma quality standardsUsed the Tianma reference extract instead of Gastrodiae rhizoma referencematerials, the result of methodology proved with good reproducibility, TLCidentification of gastrodiae rhizoma can be simple and fast.Establish TLC identification method of4-hydroxybenzyl alcohol: Tianma extractfor contesting and reference substance of4-hydroxybenzyl alcohol was used for TLCcomparison,petroleum ether-ethyl acetate (1:1) as eluent,10%phosphorus acidethanol as chromogenic reagent.The result proved the method with goodreproducibility and meet the requirements of " Chinese Pharmacopoeia". Resultsshow that this method meet the requirements for quality control of Tianma for better.Revised extract content determination method:To compare ethanol,70%ethanol,homeopathic alcohol, water, four solvents of extract content in hot-dip method.Combining with the characteristics of Tianma chemical properties andchoosing the homeopathic alcohol as the best solvent for Tianma extractdetermination.The water as solvent for extract content of the highest levels, the resultis more than20%; Secondly to homeopathic alcohol as solvent for extract contentslightly higher than the70%ethanol, the results were greater than15%; Ethanol isthe lowest, the results are less than10%. To validate the30batches of samples, andultimately determine the homeopathic alcohol as solvent, hot dipping method is usedto determine the ethanol-soluble extractives of Tianma, the extract content shall not beless than15.0%.Revised content determination method and limit: Increasing the contentdetermination of4-hydroxybenzyl alcohol on original basis. By investigating thestability of4-hydroxybenzyl alcohol, found that the thermal instability, in order toensure the accuracy of content determination results, revised the Tianma handlingmethod of test sample solution,Compared with heating reflux for2h in the originalstandard, ultrasonic processing for30min is better. Tianma calculated on dryproducts, the content including gastrodine (C13H18O7)and4-hydroxybenzylalcohol(C7H8O2) shall not be less than0.25%. To use octadecyl silane bonded silicagel as filler (column length is250mm, inner diameter is4.6mm, size5microns);themobil phase was a mixture of acetonitrile-0.05%phosphoric acid solution(3:97);Flow rate of1mL/min, the detection wavelength of220nm and column temperatureof30temperature, theoretical plate number is5000. The recovery of gastrodine was102.99%, RSD was1.67%; The recovery of4-hydroxybenzyl alcohol was96.82%,RSD was0.96%. Gastrodine linear equation is: Y=1872223.9132+2517.2833x,R2=1.0000, within the scope of0.11216to2.804μg had good linear relationship;Linear equation of4-hydroxybenzyl alcohol is: Y=3397013.2194+5336.0747x, R2=1.0000, within the scope of0.09896to2.474μg had good linear relationship.20batches of samples were determined respectively, the content including gastrodine and4-hydroxybenzyl alcohol were not be less than0.25%. Methodology verificationresults show that this method was able to control the quality of gastrodiae rhizoma from multicomponent,more scientific and reasonable evaluation.2.Drafted Tianma powder Quality StandardThis research first studied the gastrodiae rhizoma powder quality standards, andverified the10batches of Tianma powder according to the new revision of thestandard verification, the results conform to the requirements. Establish the qualitystandards of Tianma powder, not only to fill the gaps of Tianma powder qualitystandards, perfect the quality control standard of Tianma series, as well as the qualitycontrol work provides a reasonable basis in the future.3. Gastrodia elata extract in the research and preparationThis research first puts forward using Tianma contrast extract as comparison ofTLC identification method. According to the methodology of Tianma in front of theinspection work, through the multiple comparison, determine the developmentmethod of Tianma contrast extract and preparation, extracted by70%ethanol assolvent, reflux extraction twice, each time1hour, dry extract product mixture ofsodium carboxymethyl cellulose (10:1) proportion of the wet legal system grain ofquick. The results of quality stability test and verification show that the control effectsof Tianma contrast extract can meet the requirements of quality control ofTianma.Drafted the Tianma contrast extract quality standards,it provides a basis forresearch and development of other Chinese medicinal materials contrast extracts.
Keywords/Search Tags:Tianma, Tianma powder, Tianma control extract, quality standards
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